The goal of this Phase I/II clinical trial is to assess the safety and maximum tolerated training time of a self-administered computerized cognitive training (CCT) in individuals with cognitive dysfunction as a consequence of COVID-19 infection.
A Phase I/II protocol is designed to determine the safety of a Computerized Cognitive Training (CCT) aimed at ameliorating the cognitive dysfunction often observed in persons with post-acute sequelae of COVID-19 (PASC). The Phase I/II trial also aims at establishing the maximum tolerated training time per session of the CCT and to explore the feasibility of such intervention. In Phase I, through a 3+3 design, a dose-escalation trial will be set. Participants will be tested across subsequent training blocks of 15 minutes each, reporting on the experienced fatigue or adverse effects after every block. The safe training dose will be set to a block before extreme fatigue or a notable adverse effect has been reported by two or more participants. Once a safety training time has been established, a group of participants will engage in a 15-day training effectiveness assessment. After an initial thorough pre-test assessment, the intervention protocol will start. An evaluation day and a training day will be interspersed so that participants will complete a total of 8 training sessions (days 1, 3, 5, 7, 9, 11, 13 and 15). After the final day of intervention, a post-test assessment session will be carried out.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A 15-day training protocol in which every 48 hours participants' complete a series of different cognitive tasks in the form of games selected among a pool of 12 games from CogniFit (CogniFit Inc., San Francisco, USA) whose difficulty level is tailored to each individual by the a patented Individualized Training System™ (ITS) software that automatically chooses the activities and difficulty levels for each person in every session.
Universidad Nebrija
Madrid, Spain
Fatigue Level Questionnaire
Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)
Time frame: In Phase I, after each iteration of a 15-minute training.
Fatigue Level Questionnaire
Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)
Time frame: In Phase II, on even days (rest days of the intervention protocol).
Safety Level Questionnaire
Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.
Time frame: In Phase I, after each iteration of a 15-minute training.
Safety Level Questionnaire
Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.
Time frame: In Phase II, on even days (rest days of the intervention protocol).
Classification of side effect or adverse events
Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).
Time frame: In Phase I, after each iteration of a 15-minute training, only in case side effects or adverse events have been reported in the Safety Questionnaire.
Classification of side effect or adverse events
Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).
Time frame: In Phase II, on even days (rest days of the intervention protocol), only in case side effects or adverse events have been reported in the Safety Questionnaire.
Computerized Cognitive Assessment
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Complete cognitive evaluation based on Cognitive Assessment Battery (CogniFit Inc., San Francisco, USA).
Time frame: In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Quality of Life Assessment
Short version of the self-perceived global physical and mental health scale from the Patient-Reported Outcomes Measurement Information System (PROMIS v.1.2).
Time frame: In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Paper-and-pencil Cognitive Assessment
The Montreal Cognitive Assessment (MoCA).
Time frame: In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).